Enhancing PrEP Uptake and Retention Among Latine TGW and GBM in the South Using Long-Acting Injectable PrEP

THE STUDY

About this study

The purpose of this project is to test a culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW). The objective is to evaluate whether this intervention demonstrates greater persistence on lenacapavir for Latine GBM and TGW compared with what has been observed historically at the Duke PrEP Clinic.

Full official title

INCLUSION - Enhancing PrEP Uptake and Retention Among Latine Transgender Women and Gay, Bisexual, and Other Men Who Have Sex With Men in the South Using Long-Acting Injectable PrEP

Detailed description

We propose a mixed methods hybrid type 3 implementation study, which primarily tests an implementation strategy while collecting data on the clinical intervention and related outcomes. Building on existing partnerships between Duke University and El Centro Hispano, we will integrate lenacapavir delivery on-site at El Centro Hispano facilities, leveraging El Centro Hispano Peer Navigators to provide culturally congruent support for PrEP uptake, adherence, and persistence among Latine GBM and TGW.

PARTICIPATION

Who may participate

Minimum age: 18 Years
Maximum age: Not reported
Sex eligibility: Male
Healthy volunteers: Accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion criteria

Inclusion Criteria:

* Participants must be assigned male sex at birth.
* Report sexual activity with a someone assigned male at birth OR identify as GBM or TGW; be HIV-negative.
* Identify as Hispanic and/or Latine .
* Be able to provide informed consent in English or Spanish .
* Be 18 years or older .
* Weigh at least 77 lbs (35 kg) by self-reported weight.
* Interested in PrEP and willing to undergo the study procedures.

Exclusion Criteria:

* Individuals living with HIV.
* Individuals assigned female sex at birth will be excluded.
* Individuals who are currently taking oral PrEP from another source and are not willing to switch to lenacapavir for PrEP for the duration of the study will also be excluded.
* Individuals who report a history of severe renal or hepatic disease or with clinical stigmata of either disease on physical exam as assessed by a study clinician will be excluded.
* Individuals taking a medication with a significant interaction with lenacapavir will be excluded from the study.

Additional eligibility information

Latine gay and bisexual men (GBM) and transgender women (TGW)

NEAR YOU

Study locations worldwide

1 site

Check the individual site’s status and contact the listed study team for current availability.

El Centro Hispano

Recruiting

Durham, North Carolina, 27701, United States

Site contacts (3)

Orlando Martinez J Peer NavigatorContactPhone: 1(919) 687-4635Email: jomartinez@elcentronc.org

Emilia Ismael-SimentalSub investigator

Alma OrtegaSub investigator

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

Lenacapavir long-actingDrug

Culturally-tailored, community-delivered long-acting injectable PrEP (lenacapavir)

Study groups: Long-acting Injectable PrEP (lenacapavir) program

Other names: Yeztugo, Lenacapavir injection, PrEP, Injectable PrEP

Study groups

Long-acting Injectable PrEP (lenacapavir) programOther

Community-delivered long-acting injectable PrEP (lenacapavir) program for Latine gay and bisexual men (GBM) and transgender women (TGW)

Interventions: Drug: Lenacapavir long-acting

RESEARCH DETAILS

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Not applicable
Study model: Single group
Masking: None (open label)
Enrolment: 100 participants · Estimated

TIMELINE & MEASURES

Dates and outcomes

Study started: 13 Jan 2026 · Actual
Primary completion: 31 Jul 2027 · Estimated
Study completion: 31 Jul 2027 · Estimated
First registered: 20 Oct 2025 · Actual
Last registry update: 19 Oct 2026 · Actual
Status last verified: Oct 2026

Primary outcomes (4)

Acceptability of the intervention measured by questionnaire

Measured using an adapted Abbreviated Acceptability Rating Profile. Items are rated on a 5-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree); higher scores indicate greater acceptability of the intervention.

Time frame: 6 and 12 months

Feasibility of the intervention measured by programmatic indicators

Evaluated using programmatic indicators including recruitment rate, adherence and retention.

Time frame: 6 months and 12 months

Sustainability of the intervention

Number of providers who found the intervention feasible as measured by the Program Sustainability Assessment Tool (PSAT). The PSAT will provide a structured way to assess organizational capacity and sustainability for scale up. It has a score range of 0 to 40, where a higher score indicates greater feasibility.

Time frame: 6 months and 12 months

The persistence on lenacapavir among participants receiving care at El Centro Hispano at 12 months.

Persistence will be defined as the proportion of participants remaining on continuous, appropriately dosed lenacapavir at each follow-up visit. Appropriately dosed lenacapavir is defined as either on-time injection (within 28 weeks after the last injection) or with oral tablets taken as a bridge according to Package Insert instructions.

Time frame: 12 months

Secondary outcomes (7)

Persistence at 6 months

Persistence will be measured by the proportion of participants remaining on continuous, appropriately dosed lenacapavir at 6 months.

Time frame: 6 months

Adherence

Adherence measured by participants receiving each lenacapavir injection within 28 weeks after the last injectionParticipants requiring oral bridging due to delayed injections will be considered persistent but not fully adherent to the scheduled injection protocol. This is measured at 6 months and at 12 months.

Time frame: 6 months and 12 months

Retention

Retention, defined as continued receipt of appropriately dosed lenacapavir at El Centro Hispano, rather than transfer to care to another clinical site.

Time frame: 6 months and 12 months

Continuation

Continuation, defined as continued receipt of lenacapavir at El Centro Hispano, regardless of whether gaps in coverage occurred. This is measured at 12 months.

Time frame: 12 months

Patient Satisfaction measured by questionnaire

Measured with the following 4 questions: 1. Overall, how satisfied are you with lenacapavir (Likert scale)? 2. Would you recommend lenacapavir to others (yes/no)? 3. Overall, how satisfied are you with getting PrEP at El Centro (Likert scale)? 4. Would you recommend getting PrEP at El Centro to others (yes/no)? Items #1 and #3 are rated on a 5-point Likert scale from 1 (Very satisfied) to 5 (Very dissatisfied); lower scores indicate greater patient satisfaction.

Time frame: 6 months and 12 months

Quality of Life measured by questionnaire

How would you describe your health in general? (Excellent, Very good, Good, Fair, Poor)

Time frame: 6 months and 12 months

Safety measured by Adverse events

Prevalence of adverse events, such as injection site reactions.

Time frame: 6 months and 12 months

STUDY TEAM

Sponsor and contacts

Lead sponsor: Duke University
Sponsor type: Other
Collaborators: Gilead Sciences
Organisation study ID: PRO00118575

Central study contacts

Iris Navarro Clinical Research CoordinatorContactPhone: 919-660-3940Email: inclusion@duke.edu

Study officials

Tonia Poteat, PhDPrincipal investigator · Duke University Medical Center - Professor in the School of Nursing

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.